Addressing Stress Among Women Entrepreneurs in Ethiopia - Scale up

NCT05888272 | Unknown

• 1 other identifier: DWMTS-Scaleup
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine the impact of the "Doing What Matters in Times of Stress" guided self-help handbook, along with phone-based lay helpers sessions, on the psychological well-being, business performance, and incidence of intimate partner violence among women entrepreneurs in Ethiopia.

Conditions

Mental Stress; Stress; Stress, Job; Emotion Regulation; Violence, Gender-Based; Economic Problems

Keywords

Stress Managment; Psychological Wellbeing; Business Performance; Intimate Partner Violence

Outcome Measures

Primary Outcomes (12)

• Mental Distress using the Kessler Psychological Distress Scale (K-6)

  Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)

  Time Frame: 4-6 weeks post intervention

• Mental Distress using the Kessler Psychological Distress Scale (K-6)

  Minimum value of 0 and a maximum value of 24. Higher scores indicate high levels of psychological distress (worse outcome)

  Time Frame:12 months post intervention

• Depression using the Patient Health Questionnaire (PHQ-9)

  Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).

  Time Frame: 4-6 weeks post intervention

• Depression using the Patient Health Questionnaire (PHQ-9)

  Minimum score 0 and a maximum score of 27. Higher scores indicate increased levels of depressive symptoms (worse outcome).

  Time Frame: 12 months post intervention

• Stress using the Perceived Stress Scale

  Minimum score of 0 and a maximum of 40. Higher scores indicate high levels of perceived stress (worse outcome). Investigators will reverse code items 4,5, 7 and 8

  Time Frame: 4-6 weeks post intervention

• Stress using the Perceived Stress Scale

  Minimum score of 0 and a maximum of 40. Higher scores indicate high levels of perceived stress (worse outcome). Investigators will reverse code items 4,5, 7 and 8

  Time Frame: 12 months post intervention

• Self-Esteem using the Rosenberg Self-esteem Scale

  Minimum score 10 and a maximum score of 40. Investigators will reverse code items 3,5,8,9 and 10 . Higher scores indicate high levels of self-esteem (better outcome)

  Time Frame: 4-6 weeks post intervention

• Self-Esteem using the Rosenberg Self-esteem Scale

  Minimum score 10 and a maximum score of 40. Investigators will reverse code items 3,5,8,9 and 10 . Higher scores indicate high levels of self-esteem (better outcome)

  Time Frame:12 months post intervention

• World Health Organisation- Five Well-Being Index (WHO-5)

  Minimum score of 0 and a maximum of 25. Higher scores mean better wellbeing (better outcome). Scores are transformed to 0-100 (by multiplying by 4.

  Time Frame: 4-6 weeks post intervention

• World Health Organisation- Five Well-Being Index (WHO-5)

  Minimum score of 0 and a maximum of 25. Higher scores mean better wellbeing (better outcome). Scores are transformed to 0-100 (by multiplying by 4.

  Time Frame: 12 months post intervention

• Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)

  Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)

  Time Frame: 4-6 weeks post intervention

• Functional Impairment using the World Health Organization Disability Assessment Schedule (WHODAS-2.0 -12 item version)

  Minimum score of 12 and a maximum of 60. Higher scores indicate high levels of disability (worse outcome)

  Time Frame: 12 months post intervention

Secondary Outcomes (5)

• Business Performance 1

  Time Frame: 12 months post intervention

• Business Performance 2

  Time Frame: 12 months post intervention

• Business Performance 3

  Time Frame: 12 months post intervention

• Intimate Partner Violence 1

  Time Frame: 12 months post intervention

• Intimate Partner Violence 2

  Time Frame: 12 months post intervention

Study Arms (2)

Experimental - Stress Managment

EXPERIMENTAL

A locally adapted self-help guidebook originally developed by the World Health Organization (WHO), 'Doing what matters in times of stress' for managing disruptive emotions and psychological distress, will be delivered to women entrepreneurs at their residences, followed by 7 phone calls from a trained mental health helper to reinforce the materials over a 10-week period. The intervention is intended to help people manage their psychological distress associated with a range of adversities but is not intended for participants with severe mental health problems such as psychosis or imminent risk of suicide

Behavioral: Stress managment

Waitlist Control

NO INTERVENTION

This group will receive the DWMTS handbook if the study documents a positive impact on the outcomes of interest.

Interventions

Stress managment BEHAVIORAL

The Doing What Matters in Times of Stress self-help manual materials and lay helper scripts utilized in the study are rooted in the principles of Acceptance and Commitment Therapy (ACT). They are designed to improve psychological flexibility which refers to an individual's ability to adapt to changing situations, reallocate mental resources, shift perspectives, and balance competing priorities. The ACT approach teaches individuals how to manage challenging thoughts and emotions through mindfulness techniques, while also guiding them to live in alignment with their personal values.

Also known as: Doing What Matters in Times of Stress self-help hand book - the intervention does not involve any drugs.

Experimental - Stress Managment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifying as women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18;
• Those who plan to live in the study city in the next six months;
• Those who can read and speak Amharic and can understand the study questionnaire;
• Those who have the capacity to provide informed consent;
• Score 8 or above on the Ethiopian adaptation of Kessler-6

You may not qualify if:

• Kessler 6 score \>20;
• Those who have recent or current suicidal thoughts or plans;
• Those who have limitations in understanding the study questionnaire;
• Those who do not have the capacity to provide informed consent;
• Do not have access to a phone;
• Not interested in receiving the intervention

Sponsors & Collaborators

• World Bank: lead
• Ethiopian Medical Association: collaborator
• Policy Studies Institute: collaborator
• Addis Ababa University: collaborator

Study Sites (1)

Policy Studies Institute

Addis Ababa, Ethiopia

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Occupational Stress; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Diseases; Self-Control; Social Behavior

Study Officials

• Adiam Hagos Hailemicheal, MSc

  World Bank

  PRINCIPAL INVESTIGATOR

• Naira Kalra, PhD

  World Bank

  PRINCIPAL INVESTIGATOR

• Medhin Selamu Tegegn, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

• Kassahun Habtamu Mekonnen, PhD

  Addis Ababa University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adiam Hagos Hailemicheal, MSc

CONTACT

7038431640; ahailemicheal@worldbank.org

Medhin Selamu Tegegn, PhD

CONTACT

+251919372313; medhins10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomized using computer-generated randomization at one point in time.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants that meet the eligibility criteria are randomly assigned to the intervention and waitlist control groups.

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: June 5, 2023
• Study Start: April 4, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Baseline survey - April, 2025; Follow up surveys - July, 2025
• Access Criteria: The data will be publicly available on the World Bank's microdata website. Use of the dataset must be acknowledged using a citation which would include: 1. the identification of the Principal Investigators, 2. the title of the survey (including country, acronym and year of implementation) 3. the survey reference number 4. the source and date of download

Locations

ET (1)